Qualities of Sore Throat Index (QuaSTI): Measuring Descriptors of Sore Throat in a Randomized, Placebo-Controlled Trial

Abstract

Aim: Patients with pharyngitis often describe various sensory, affective and evaluative pain qualities. Using an 11-word/phrase index, the Qualities of Sore Throat Index (QuaSTI), we characterized throat symptoms and evaluated changes in a randomized controlled trial (NCT01986361). Materials & methods: Patients received a single flurbiprofen 8.75 mg (n = 101) or placebo (n = 21) lozenge and rated throat soreness at baseline and regular intervals over 3 h, and the QuaSTI at baseline, 1, 2 and 3 h post-treatment. Results: The QuaSTI distinguished active drug from placebo and detected clinically important (≥2-point) changes over 3 h. Mean change from baseline over 3 h was significantly greater for flurbiprofen (154%) than placebo (p < 0.05). Conclusion: The QuaSTI is a sensitive instrument for measuring therapeutic effects in patients with pharyngitis.

Keywords::

• flurbiprofen
• pharyngitis
• sore throat

Acknowledgements

Celerion (Belfast, Northern Ireland, UK) performed the statistical analyses. The authors are grateful for the additional statistical analyses provided by A Smith and B Jenner of Reckitt Benckiser Healthcare Ltd. Statistical support was provided by G Smith (formerly an employee of Reckitt Benckiser Healthcare Ltd).

Financial & competing interests disclosure

A Shephard and T Shea are employees of Reckitt Benckiser Healthcare Ltd, UK and Reckitt Benckiser, Parsippany, New Jersey, USA, respectively. S Aspley was an employee of Reckitt Benckiser Healthcare Ltd, UK during the preparation of the manuscript. B Schachtel, MB Lorton and E Schachtel (at Schachtel Research Company) received a research grant from Reckitt Benckiser to design and conduct the study. This study was funded by Reckitt Benckiser Healthcare Ltd, UK. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Medical writing assistance was provided by Elements Communications Ltd, Westerham, UK and was funded by Reckitt Benckiser Healthcare Ltd, UK.

Ethical conduct of research

Ethical approval was obtained from the University’s Institutional Review Board. The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved. It complied with ICH GCP and US GCP regulations in the Code of Federal Regulations, and was registered on the ClinicalTrials.gov registry (NCT01986361) on 18 November 2013.

Additional information

Funding

A Shephard and T Shea are employees of Reckitt Benckiser Healthcare Ltd, UK and Reckitt Benckiser, Parsippany, New Jersey, USA, respectively. S Aspley was an employee of Reckitt Benckiser Healthcare Ltd, UK during the preparation of the manuscript. B Schachtel, MB Lorton and E Schachtel (at Schachtel Research Company) received a research grant from Reckitt Benckiser to design and conduct the study. This study was funded by Reckitt Benckiser Healthcare Ltd, UK. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Medical writing assistance was provided by Elements Communications Ltd, Westerham, UK and was funded by Reckitt Benckiser Healthcare Ltd, UK